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510(k) Data Aggregation
K Number
K140683Device Name
0180 INTUITION, 0072 PRECISION
Manufacturer
ARCOMA AB
Date Cleared
2014-06-03
(77 days)
Product Code
KPR
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
ARCOMA AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
These are stationary x-ray systems intended for obtaining radiographic images of various portions of the human body in a clinical environment. The devices are not intended for mammography
Device Description
This is a complete stationary diagnostic x-ray system employing digital x-ray panels coupled with image acquisition software. The key features are: Ceiling Tube Suspension, Motorized Movements, Auto-Positioning, Tube Mounted 10" Touch Screen, Elevating 6 Way Table Patient Load: 5501bs, Single User Interface, High Frequency Generator. This ergonomic design incorporates automatic motorized positioning, creating an efficient workflow increasing the patient throughput. Precision offers automatic stitching enhancing the workflow further. Tube, vertical wall stand and table have extended range of motion for easy patient positioning. The acquisition software is installed on a Windows compatible workstation. The high frequency generator is available in different power ratings. All components are either 510(k) exempt or previously cleared. Generators are available in 50, 65, 80 kW (High Frequency) models.
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K Number
K073632Device Name
INTUITION, MODEL 0170
Manufacturer
ARCOMA AB
Date Cleared
2008-01-10
(15 days)
Product Code
KPR
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
ARCOMA AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 0170 Intuition is a stationery x-ray system intended for obtaining radiographic images of various portions of the human body in a clinical environment. The 0170 Intuition is not intended for mammography.
Device Description
The 0170 Intuition is a stationary x-ray system with a ceiling mounted tube stand, a floor mounted table and a wall stand that has a floor mounted column with a detector holder. The ceiling stand and the table has automatic movements for up and downs, other movements are manual. The standard equipment includes a graphic display showing X-ray tube rotation and film focus or source image distance.
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